TrailBlazer™ ASC-014-150Recalls & reported problems
Medtronic, Inc. · PS ASC-014-150 TRAILBLAZER ANGLED V04 · Class 2
All models of TrailBlazer (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000770310), received between Mar 25, 2026 and Mar 25, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY PROCEDURE INVOLVING THE TRAILBLAZER ANGLED SUPPORT CATHETER IN THE TIBIAL/POPLITEAL TRUNK, DETACHMENT/FRACTURE OF THE DEVICE TIP OCCURRED. THE TIP WAS BROKEN BUT REMAINED ATTACHED TO THE CATHETER. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE THAT WAS NOT A MEDTRONIC PRODUCT. THE PATIENT WAS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24685666 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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